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Mechanics of Knee Bracing

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

pneumatic brace

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Knee Osteoarthritis, pneumatic bracing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

knee pain, aching or stiffness on most of the past 30 days
x-ray verified predominant medial tibiofemoral osteoarthritis (TFOA)
overall pain that is due to the medial TFOA (versus being referred from the back, hips, or other pre-existing conditions)
ambulatory persons

Exclusion Criteria:

use of a crutch, walker, or wheelchair or cane more than 50% of the time
history of Deep Vein Thrombosis
Pain emanating more from back or hip than from knee
Low pain score on WOMAC
predominant patellofemoral disease or knee pathology other than medial compartment OA likely to be causing their knee pain.
Planning to move from area within 1 month of study screening.
Unable to fit the brace properly
BMI greater than 35
corticosteriod injections in the past month
Bilateral total knee replacements or plan for TKR
Other types of arthritis including Rheumatoid Arthritis, Systemic Lupus Erythematosus, gout, psoriatic arthritis, pseudogout.
woman who are pregnant (due to x-rays taken to determine eligibility)

Sites / Locations

New England Baptist Hospital

Outcomes

Primary Outcome Measures

To undertake a clinical trial in patients with medial knee OA to determine whether provision of a pneumatic knee brace leads to a reduced adduction moment during the time of this treatment than during the use of a control treatment.

Secondary Outcome Measures

To undertake a clinical trial in patients with medial knee OA to determine whether provision of a pneumatic knee brace leads to a lower pain score and improved function during the time of this treatment than during the use of a control treatment.

Full Information

NCT ID

NCT00823888

First Posted

January 15, 2009

Last Updated

July 19, 2011

Sponsor

The New England Baptist Hospital

Collaborators

Boston University, Spaulding Rehabilitation Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00823888

Brief Title

Mechanics of Knee Bracing

Official Title

Mechanics of Knee Bracing

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

The New England Baptist Hospital

Collaborators

Boston University, Spaulding Rehabilitation Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The overall objective of this project is to determine whether the provision of a pneumatic knee brace in patients with medial knee osteoarthritis (OA) improves knee mechanics. Secondary objectives will be to assess if the brace relieves knee pain and improves function. We will test the hypothesis that compared to the control treatment (see below for the definition) the use of a pneumatic knee brace is effective in medial knee OA.

Detailed Description

This study is closed to enrollment and in the data analysis phase

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

Keywords

Knee Osteoarthritis, pneumatic bracing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

pneumatic brace

Intervention Description

pneumatic knee brace with three trial conditions: air bladders inflated at 0psi, 7 psi, and 12 psi

Primary Outcome Measure Information:

Title

Time Frame

At study visit

Secondary Outcome Measure Information:

Title

Time Frame

During study visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: knee pain, aching or stiffness on most of the past 30 days x-ray verified predominant medial tibiofemoral osteoarthritis (TFOA) overall pain that is due to the medial TFOA (versus being referred from the back, hips, or other pre-existing conditions) ambulatory persons Exclusion Criteria: use of a crutch, walker, or wheelchair or cane more than 50% of the time history of Deep Vein Thrombosis Pain emanating more from back or hip than from knee Low pain score on WOMAC predominant patellofemoral disease or knee pathology other than medial compartment OA likely to be causing their knee pain. Planning to move from area within 1 month of study screening. Unable to fit the brace properly BMI greater than 35 corticosteriod injections in the past month Bilateral total knee replacements or plan for TKR Other types of arthritis including Rheumatoid Arthritis, Systemic Lupus Erythematosus, gout, psoriatic arthritis, pseudogout. woman who are pregnant (due to x-rays taken to determine eligibility)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William F Harvey, MD

Organizational Affiliation

New England Baptist Hospital, Tufts Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

New England Baptist Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02120

Country

United States

12. IPD Sharing Statement

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Mechanics of Knee Bracing

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